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TERMINATEDPHASE3

Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

A Multi-center, Randomized, Double Blind, Placebo Controlled Study to Investigate the Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients With Bladder Cancer Undergoing Radical or Total Cystectomy.

NCT00306150•Bayer

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess if aprotinin (BAYA0128), given intravenously during your surgery, is safe and can help reduce the need for a blood transfusion during bladder surgery.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subjects 18 years of age and older
•Subjects requiring elective radical or total cystectomy for bladder cancer
•Documented, signed, dated informed consent obtained prior to any study specific procedures being performed

Exclusion Criteria

•Subjects with previous exposure to aprotinin in the last 6 months or with a known or suspected allergy to aprotinin
•Subjects with sepsis or undergoing laparoscopic surgery
•Subjects with impaired renal function (serum creatinine \>2.5 mg/dL or 221 micromoles/liter)
•Subjects with a history of bleeding diathesis, deep vein thrombosis or pulmonary embolism or known coagulation factor deficiency. Based on the investigator's opinion of any active significant medical illness the subject may have
•Subjects who refuse to receive allogenic blood products or whose preoperative red blood cell volume is so low that a blood transfusion would be likely to be given perioperatively (preoperative hematocrit of \<24% or hemoglobin of \<8 g/dl)
•Subjects who have participated in an investigational drug study within the past 30 days
•Subjects who are pregnant or breastfeeding or women of childbearing potential in whom the possibility of pregnancy cannot be excluded by a negative pregnancy test and who are not using a reliable method of contraception
•Planned use of other antifibrinolytic agents, e.g. aminocaproic acid or tranexamic acid
•Subjects on chronic anticoagulant treatment with warfarin that cannot be temporarily discontinued for the surgical procedure (as per local practices)

Locations (37)

Los Angeles, California, United States

Denver, Colorado, United States

Miami, Florida, United States

Chicago, Illinois, United States

Portland, Maine, United States

Baltimore, Maryland, United States

Ann Arbor, Michigan, United States

Rochester, Minnesota, United States

Chapel Hill, North Carolina, United States

Key Dates

Start Date

December 1, 2005

Completion Date

March 1, 2007

Last Updated

December 17, 2014

Enrollment

ACTUAL participants

Conditions

Blood Loss, SurgicalPostoperative Hemorrhage

Interventions

Trasylol (Aprotinin, BAYA0128)

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 17, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy

Inclusion Criteria

Exclusion Criteria

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